Effectiveness of tDCS for the Treatment of Functional Dyspepsia

Dyspepsia Clinical Trial

Official title:

Effectiveness of Transcranial Direct Current Stimulation for the Treatment of Functional Dyspepsia: a Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02611414
• Other study ID #: 50793815900005304
• Status: Recruiting
• Phase: Phase 2/Phase 3
• First received: November 17, 2015
• Last updated: May 17, 2016
• Start date: January 2016
• Est. completion date: January 2020

Study information

• Verified date: March 2016
• Source: Hospital Ernesto Dornelles
• Contact: Carine Leite, MD
• Phone: 55 51 97420351
• Email: carineleite[@]hotmail.com
• Is FDA regulated: No
• Health authority: Brazil: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

Functional dyspepsia is a very common disorder of great challenge to clinical management. A therapeutic targets is up-regulation of visceral pain threshold. The transcranial direct current stimulation (tDCS) is a novel therapy that pursues these properties, besides its safety and easy adherence. There is a great need of new treatments for functional dyspepsia. There is no current study evaluating tDCS for this disease.

Description:

Functional dyspepsia is a high prevalent disease with substantial costs to health system. There are many available treatments, but disappointing results are reported in clinical trials.

TDCS is a noninvasive, secure and painless technique of brain stimulation. It is delivered by a battery-operated device that transfers low intensity electrical current to all surface of the brain. Then there is a modulation of cortical excitability and influence on central neurological functions. It has been reported its efficacy for the treatment of many diseases such as depression and chronic pain.

Impairment of central mechanisms of interpretation and threshold of pain are related to functional dyspepsia. Therefore, tDCS may benefit dyspeptic patients.

This study is a double blind randomized controled trial to test tDCS effectiveness on functional dyspepsia. Seventy functional dyspeptic patients will be enrolled, being randomized to either tDCS or sham tDCS.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 70
• Est. completion date: January 2020
• Est. primary completion date: January 2019
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• functional dyspeptic patients according to Rome IV criteria

• clinical investigation reporting absence of organic causes of functional dyspepsia

Exclusion Criteria

• history of brain trauma, haemorrhage or ischemia

• implantable devices such as pacemaker

• alcohol or drug abuse

• epilepsy

• severe chronic disease

• non-acceptance to sign up the term of consent.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dyspepsia

Intervention

Device:
• anodal tDCS
tDCS anodal stimulation over M1 area applied for 20 minutes at five consecutive days.
• Sham tDCS
tDCS sham stimulation over M1 applied for 20 minutes (with current turned off at 30 seconds) at five consecutive days.

Locations

Country	Name	City	State
Brazil	Hospital Ernesto Dornelles - Endoscopy Unit	Porto Alegre	RS

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Ernesto Dornelles

Country where clinical trial is conducted

Brazil, 

References & Publications (3)

Brunoni AR, Nitsche MA, Bolognini N, Bikson M, Wagner T, Merabet L, Edwards DJ, Valero-Cabre A, Rotenberg A, Pascual-Leone A, Ferrucci R, Priori A, Boggio PS, Fregni F. Clinical research with transcranial direct current stimulation (tDCS): challenges and future directions. Brain Stimul. 2012 Jul;5(3):175-95. doi: 10.1016/j.brs.2011.03.002. Epub 2011 Apr 1. Review. — View Citation

Ma TT, Yu SY, Li Y, Liang FR, Tian XP, Zheng H, Yan J, Sun GJ, Chang XR, Zhao L, Wu X, Zeng F. Randomised clinical trial: an assessment of acupuncture on specific meridian or specific acupoint vs. sham acupuncture for treating functional dyspepsia. Aliment Pharmacol Ther. 2012 Mar;35(5):552-61. doi: 10.1111/j.1365-2036.2011.04979.x. Epub 2012 Jan 16. — View Citation

Marlow NM, Bonilha HS, Short EB. Efficacy of transcranial direct current stimulation and repetitive transcranial magnetic stimulation for treating fibromyalgia syndrome: a systematic review. Pain Pract. 2013 Feb;13(2):131-45. doi: 10.1111/j.1533-2500.2012.00562.x. Epub 2012 May 28. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Adverse reactions	A questionnaire to point out if presence of one or more of the 8 previously reported adverse effects of tDCS (such as headache and burning sensation).	Daily from day of inclusion until day 5	Yes
Primary	PADYQ score	Decrease in PADYQ (Porto Alegre Dyspepsia Symptoms Questionnaire) score	4 weeks	No
Secondary	HADS score	Decrease in HADS score	4 weeks	No
Secondary	SF36 score	Decrease in SF36 score	4 weeks	No
Secondary	Use of drugs for dyspeptic symptoms	Questionnaire about the drugs and number of weekly pills used for symptomatic relief of functional dyspepsia symptoms	1 and 4 weeks	No
Secondary	Self-reported treatment response	Questionnaire for self-reporting and graduating: worsening/no improvement/improvement after treatment	1 and 4 weeks	No